Several techniques have been used in the past for the treatment of tissue including diseased tissue, such as cancer, to remove, destroy, or otherwise minimize the growth of the diseased tissue. For example, traditional methods of treating diseased prostate tissue include high intensity focused ultrasound (“HIFU”), radiation, surgery, Brachytherapy, cryoablation, hormonal therapy, and chemotherapy. Described herein are improved apparatus and methods for treating tissue with HIFU.
Although the techniques, methods, and apparatus discussed herein have applicability to the treatment of tissue in general, this discussion will focus primarily on the treatment of prostate tissue including Benign Prostatic Hyperplasia (BPH) and prostatic cancer. However, the disclosed apparatus and methods will find applications in localization and treatment of a wide range of diseases which manifest themselves in a localized or “focal” manner, including cancers of the breast, brain, liver, and kidney. As explained herein, the disclosed apparatus uses an intracavity probe which will be particularly useful for focal diseases which are accessible to a transesophageal, laparoscopic or transvaginal probe. Such diseases include esophageal cancer, cancer in the trachea and urethra, ulcers in the stomach and duodenum, and pancreatic cancer. Moreover, a transvaginal probe according to the present invention will provide a minimally invasive sterilization procedure on an outpatient basis, as well as therapy for fibroids, and endometrial ablation. Additionally, in the case of a transducer with multiple focal lengths, blood vessels may be selectively targeted to effect coagulation and cauterization of internal bleeding.
As used herein the term “HIFU Therapy” is defined as the provision of high intensity focused ultrasound to a portion of tissue at or proximate to a focus of a transducer. It should be understood that the transducer may have multiple foci and that HIFU Therapy is not limited to a single focus transducer, a single transducer type, or a single ultrasound frequency. As used herein the term “HIFU Treatment” is defined as the collection of one or more HIFU Therapies. A HIFU Treatment may be all of the HIFU Therapies administered or to be administered, or it may be a subset of the HIFU Therapies administered or to be administered. As used herein the term “HIFU System” is defined as a system that is at least capable of providing a HIFU Therapy.
In an exemplary embodiment of the present disclosure, an apparatus for treating tissue in a treatment region is provided. The apparatus comprising a transducer which is positionable proximate to the tissue and a positioning member coupled to the transducer and configured to position the transducer. The transducer being configured to emit ultrasound energy and to receive ultrasound energy. The apparatus further comprising a controller operably coupled to the transducer and to the positioning member. The controller being configured to position the transducer with the positioning member and to operate the transducer in an imaging mode wherein images of the tissue in the treatment region are obtained from ultrasound energy sensed by the transducer and in a therapy mode wherein a plurality of treatment sites are treated with a HIFU Therapy with the transducer. The controller being further configured to monitor a plurality of regions of interest in the treatment region and to determine a tissue change value for each region of interest based on a frequency analysis of at least two images of the plurality of images. Each region of interest corresponding to a multi-dimensional portion in each of the at least two images.
In another exemplary embodiment of the present disclosure, an apparatus for treating tissue in a treatment region is provided. The apparatus comprising a transducer which is positionable proximate to the tissue, the transducer being configured to emit ultrasound energy and to receive ultrasound energy; a positioning member coupled to the transducer and configured to position the transducer; and a controller operably coupled to the transducer and to the positioning member. The controller including means for determining a tissue change value for a region of interest in the treatment region.
In a further exemplary embodiment of the present disclosure, a method of providing treatment to a treatment region of tissue is provided. The method comprising the steps of acquiring a first image including a treatment site prior to a direct treatment with a HIFU Therapy, performing the direct treatment of the treatment site with the HIFU Therapy, acquiring a second image including the treatment site subsequent to the direct treatment, and determining a tissue change value in a region of interest of the tissue based on a first power spectrum of a portion of the first image corresponding to the region of interest and a second power spectrum of a portion of the second image corresponding to the region of interest. The first image being a multi-dimensional image. The second image being a multi-dimensional image. The region of interest including the treatment site.
In still another exemplary embodiment of the present disclosure, a method of providing treatment to a treatment region of tissue is provided. The method comprising the steps of: monitoring a level of a tissue change in a region of interest of the treatment region due to an indirect heating of the tissue in the region of interest in response to a direct treatment of at least one treatment sites with the HIFU Therapy in the treatment region outside of the region of interest and determining whether to provide a direct treatment with the HIFU Therapy to a treatment site within the region of interest based on the level of the tissue change. The level of the tissue change being determined by a comparison of the power spectra of at least two images including the region of interest.
In still a further exemplary embodiment of the present disclosure, a method of providing treatment to a treatment region of tissue is provided. The method comprising the steps of: performing acquiring a first image including a treatment site prior to a direct treatment with a HIFU Therapy, the first image being a multi-dimensional image; performing the direct treatment of the treatment site with the HIFU Therapy; acquiring a second image including the treatment site subsequent to the direct treatment, the second image being a multi-dimensional image; determining an indication of a tissue change in a region of interest of the tissue from a frequency domain analysis of the first image and the second image; and providing a color-coded visual indicator on an image of the treatment region. The color-coded visual indicator providing an indication of a degree of tissue change.
Additional features of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of the illustrative embodiments exemplifying the best mode of carrying out the invention as presently perceived.